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Feasibility and acceptability of LNG 1.5 mg as an on-demand pericoital contraceptive in Ghana
Globally, there is a need for more family planning method options as currently, available options do not adequately meet the needs of women, specifically those who have infrequent sex. Levonorgestrel (LNG) 1.5 mg is widely available as emergency contraception pills (ECP), and recent research has shown that certain women take it as their main form of contraception. Furthermore, limited studies have found repeat, on-demand use safe and efficacious.This 12-month prospective, single-arm, interventional study in Ghana tested whether a single LNG 1.5 mg on-demand or pericoital (“around the time of sex”) dose contraceptive was acceptable to women who have infrequent sex and if pharmacy provision was feasible. The study sample (1,890) comprised women of reproductive age recruited from urban areas, having infrequent sex (i.e., coital frequency ≤ 6× per month), and not using any other modern methods except condoms or ECP at the time of study inclusion.Results indicated that there is demand and acceptability for a pericoital pill and that pharmacy provision is feasible. Furthermore, precoital use of the pill had high levels of satisfaction and was popular with new users. Adding LNG 1.5 mg for pericoital use to the family planning method mix has the potential to address an important segment of the population currently underserved, decreases unwanted pregnancies, and increases modern contraceptive prevalence rates
Findings from a mixed methods evaluation of an integrated social and behavior change approach to improve health outcomes in Niger
This brief summarizes findings from a mixed methods evaluation of an integrated social and behavior change (SBC) approach implemented in the Maradi and Zinder regions of Niger. It is intended to inform the Resilience in the Sahel Enhanced (RISE) II program implemented by the United States Agency for International Development (USAID) funded Resilience Food Security Activities (RFSA) to further improve reproductive, maternal, and child health outcomes. This brief provides an overview of the integrated SBC approach and evaluation methods and then guided by the program theory of change, describes the mechanisms through which the intervention contributed to change in health behaviors by considering programmatic exposure, behavioral determinants, and contextual factors. The brief then presents findings on the effectiveness of integrated SBC programming on family planning, maternal health outcomes, nutrition and water, sanitation, and hygiene behaviors. The brief concludes with recommendations to improve implementation to achieve improved health outcomes
Evidence from the implementation of a social accountability approach to improve family planning services: Perspectives from community members and health workers in Togo
This brief summarizes findings from Breakthrough RESEARCH\u27s formative qualitative evaluation of a social accountability approach implemented in and around the city of Lomé, Togo to strengthen family planning (FP) services. It is intended to inform FP programs implemented by the USAID-funded West Africa Breakthrough ACTION (WABA) and AmplifyPF projects to further improve FP related outcomes. This brief provides an overview of the social accountability approach and describes the enabling factors and challenges associated with implementation as well as perceived outcomes related to the effectiveness of the social accountability approach to improve FP service delivery at the community level, at the facility, and in terms of client and provider interactions. The brief concludes with strategies to leverage these findings to improve implementation to achieve increased FP client satisfaction service utilization
Comment mesurer l’impact du changement de comportement des prestataires
Développé par Breakthrough RESEARCH, ce guide a pour but d\u27aider les planificateurs et les concepteurs de programmes à mieux comprendre les initiatives de changement de comportement des prestataires (CCP) et leur impact sur la prestation et la qualité des services. Ce guide vise également à faire progresser la mesure du CCP en fournissant des cadres et des exemples illustratifs de la manière dont la mesure du CCP peut éclairer la planification et la conception des programmes. Enfin, le guide propose des moyens de continuer à développer la base de données probantes pour les approches et l\u27impact du CCP
Where there is a will, there is a way: Enhancing contraceptive uptake in Pakistan
Objective: To assess the contribution of a series of interventions on contraceptive uptake and reduction in unmet need in areas covered by the Family Advancement for Life and Health project. Methods: The study was conducted from 2008–09 to 2011–12 in 14 districts across Pakistan. The sample comprised all urban and rural households in each district. A total or 40 blocks/villages were selected, with 13 households selected per block/village. Within each household, all married women of reproductive age 15-49 years were interviewed, and their husbands who were present at the time were also interviewed to a maximum of 5 per block. Baseline data was collected in 2008-09, while end line data was collected in 2010–11. Change in family planning uptake attributed to the project interventions were estimated. Besides, a situation analysis of service delivery points was also conducted. Data was analysed using SPSS 21. Results: The panel comprised 5,304 women and 950 husbands. Interventions with the most robust effects were LHWs\u27 home visits, attending women\u27s group meetings, and watching family planning messages on television (p \u3c 0.05). The greatest changes were observed in Khyber Pakhtunkhwa province, in urban areas and among younger women (p \u3c 0.05). Conclusions: Investing in public-sector services does pay off in terms of meeting family planning needs, and so do better, wider and clearer communication
Development and biophysical characterization of a humanized FSH-blocking monoclonal antibody therapeutic formulated at an ultra-high concentration
Highly concentrated antibody formulations are oftentimes required for subcutaneous, self-administered biologics. Here, we report the development of a unique formulation for our first-in-class FSH-blocking humanized antibody, MS-Hu6, which we propose to move to the clinic for osteoporosis, obesity, and Alzheimer\u27s disease. The studies were carried out using our Good Laboratory Practice (GLP) platform, compliant with the Code of Federal Regulations (Title 21, Part 58). We first used protein thermal shift, size exclusion chromatography, and dynamic light scattering to examine MS-Hu6 concentrations between 1 and 100 mg/mL. We found that thermal, monomeric, and colloidal stability of formulated MS-Hu6 was maintained at a concentration of 100 mg/mL. The addition of the antioxidant L-methionine and chelating agent disodium EDTA improved the formulation\u27s long-term colloidal and thermal stability. Thermal stability was further confirmed by Nano differential scanning calorimetry (DSC). Physiochemical properties of formulated MS-Hu6, including viscosity, turbidity, and clarity, confirmed with acceptable industry standards. That the structural integrity of MS-Hu6 in formulation was maintained was proven through Circular Dichroism (CD) and Fourier Transform Infrared (FTIR) Spectroscopy. Three rapid freeze-thaw cycles at -80 °C/25 °C or -80 °C/37 °C further revealed excellent thermal and colloidal stability. Furthermore, formulated MS-Hu6, particularly its Fab domain, displayed thermal and monomeric storage stability for more than 90 days at 4°C and 25°C. Finally, the unfolding temperature (Tm) for formulated MS-Hu6 increased by \u3e4.80 °C upon binding to recombinant FSH, indicating highly specific ligand binding. Overall, we document the feasibility of developing a stable, manufacturable and transportable MS-Hu6 formulation at a ultra-high concentration at industry standards. The study should become a resource for developing biologic formulations in academic medical centers
Drug reprofiling to identify potential HIV-1 protease inhibitors
The use of protease inhibitors in human immunodeficiency virus type 1 (HIV-1) treatment is limited by adverse effects, including metabolic complications. To address these challenges, efforts are underway in the pursuit of more potent and less toxic HIV-1 protease inhibitors. Repurposing existing drugs offers a promising avenue to expedite the drug discovery process, saving both time and costs compared to conventional de novo drug development. This study screened FDA-approved and investigational drugs in the DrugBank database for their potential as HIV-1 protease inhibitors. Molecular docking studies and cell-based assays, including anti-HIV-1 in vitro assays and XTT cell viability tests, were conducted to evaluate their efficacy. The study findings revealed that CBR003PS, an antibiotic currently in clinical use, and CBR013PS, an investigational drug for treating endometriosis and uterine fibroids, exhibited significant binding affinity to the HIV-1 protease with high stability. Their EC50 values, measured at 100% cell viability, were 9.4 nM and 36.6 nM, respectively. Furthermore, cell-based assays demonstrated that these two compounds showed promising results, with therapeutic indexes higher than 32. In summary, based on their favorable therapeutic indexes, CBR003PS and CBR013PS show potential for repurposing as HIV-1 protease inhibitors
Webinar—Costing for Family Planning Social and Behavior Change
Breakthrough RESEARCH, USAID’s flagship social and behavior change (SBC) research and evaluation project to drive the generation, packaging, and use of innovative SBC research to inform programming, held the last of four interactive legacy and learning events. This event in the series on costing for family planning SBC highlighted evidence, insights, and learnings over the life of the project to gather, analyze, and share evidence on the costs and impact of SBC interventions, making the case that investing in SBC is crucial for improving health, including family planning outcomes. Understanding and measuring project costs and cost drivers is important for developing a consistent evidence base for SBC programs to support family planning programs, inform adaptive management, and ensure continued investments in evidence-based, cost-effective SBC approaches
The methodological approach to a process evaluation of a community and provider-driven social accountability intervention to increase contraceptive uptake and use
The community and provider-driven social accountability intervention (CAPSAI) project was a complex intervention consisting of interacting components, actors and processes, implemented in Ghana and Tanzania from 2018 to 2020. It aimed to measure the impact of a social accountability intervention implemented in family planning services, on contraceptive uptake and use. The intervention incorporated a process evaluation to identify key causal pathways and better understand factors influencing uptake and use, in the context in which the intervention was implemented. This study used a unique methodology to conduct the process evaluation, and looked at several outcomes, including service utilisation, continuation rates and attitudes and behaviours. Qualitative methods were used to evaluate the effects of the intervention – (1) context mapping, (2) a process evaluation of the different steps of the intervention, and (3) compiling cases of change. Document review, non-participant observation and in-depth interviews were conducted. Data analysis included summaries and coding of the qualitative data. Coding and thematic content analysis were conducted collaboratively across two countries and used a single codebook that was relevant to both countries, yet enabled country specific analysis. Each country team drafted reports that drew on the three data sets. Various lessons were learnt – including the importance of teamwork, development of standard operating procedures to guide practical study components, and how to prioritise study activities over a long study timeline. The study demonstrated that a process evaluation of a complex intervention across multiple countries is feasible, and was also able to yield differentiate results based on specificity in each country’s context. Based on this study, similar process evaluation activities can be replicated in future work
Revitalizing Intermittent Preventive Treatment of Malaria in Pregnancy in Kenya
Nearly a third of Kenya’s 51 million people live in malaria-endemic zones and pregnant women are especially susceptible to malaria infection. Intermittent preventive treatment of malaria in pregnancy (IPTp) using sulfadoxine-pyrimethamine (SP) helps prevent maternal malaria episodes, maternal and fetal anemia, placental parasitemia, low birth-weight, and neonatal mortality. WHO’s guidelines on IPTp recommend that pregnant women living in moderate to high malaria transmission areas in sub-Saharan Africa receive a dose of SP at each antenatal care visit, beginning in the second trimester. IPTp-SP is recommended alongside insecticide-treated nets and appropriate case management. Kenya adopted WHO’s recommendations in 1998, however IPTp-SP uptake by pregnant women remains low. As stated in this fact sheet, the Population Council-Kenya is leading the 2020-2025 REVIVE IPTp-SP project, which seeks to contribute to the government of Kenya’s national target of 80% coverage of IPTp-SP for MiP by 2025. The project is implementing interventions to increase IPTp-SP coverage in two high-prevalence malaria-endemic counties in Kenya, Migori and Kisumu, through: policy clarification and consensus building, capacity building and strengthening, promoting user empowerment and self-care for the communities and pregnant mothers, and Improving monitoring, evaluation, and shared learning